Assays

Embrace performance for detection of Clostridioides difficile infection (CDI)*

The BD MAXTM Cdiff assay provides rapid detection of the C. difficile toxin B gene (tcdB),
the gene essential for CDI1, including infections caused by hypervirulent strains

  • CDI is the most important (preventable) infective cause of healthcare-associated diarrhoea in Europe and is associated with high morbidity and mortality2
  • The BD MAX™ Cdiff assay is a real time polymerase chain reaction (PCR) assay offering diagnostic speed and accuracy to allow fast treatment decisions and prevent transmission of infection3
  • Traditional diagnostic methods can be time-consuming (toxigenic culture or cell cytotoxicity neutralization assay) or may have poor sensitivity (glutamate dehydrogenase assays)4-5
  • PCR is recommended by ESCMID guidelines as a primary test in a 2-step algorithm for diagnosis of CDI2
  • The BD MAX™ Cdiff assay is integrated on the fully automated BD MAX™ System and is run compatible with
    other healthcare associated infection (HAI) assays3
  • Results are available in approximately 2 hours with only 1 minute of hands-on time per specimen3
Improved patient management

Improved patient
management

Improved workflow

Workflow
efficiency

Increased accuracy of detection

Diagnostic
accuracy


Characteristics of the BD MAX™ Cdiff assay

Test Sample type2 Storage and Stability2 Target
BD MAX™ Cdiff
  • Unpreserved stool
  • Specimens can be stored for up to 120 hours (5 days) at 2–8°C or for up to 48 hours at 2–25°C before testing
  • Transport should occur at 2–25°C
  • Clostridioides difficile* toxin B gene (tcdB)
Test BD MAX™ Cdiff
Sample type2
  • Unpreserved stool
Storage and Stability2
  • Specimens can be stored for up to 120 hours (5 days) at 2–8°C or for up to 48 hours at 2–25°C before testing
  • Transport should occur at 2–25°C
Target
  • Clostridioides difficile* toxin B gene (tcdB)

*Clostridioides difficile was previously known as Clostridium difficile, the bacteria was reclassified in 2016


CDI
, Clostridioides difficile infection; CPO, Carbapenemase-Producing Organism; ESCMID, European Society of Clinical Microbiology and Infectious Diseases; HAI, Healthcare Associated Infections; MRSA, Methicillin-Resistant Staphylococcus aureus; PCR, Polymerase Chain Reaction; tcdB, Clostridioides difficile toxin B gene

 

1. Polage C et al. Clin Infect Dis. 2012;55(7):982-989. 2. Tschudin-Sutter S et al. Clin Microbiol Infect. 2018;24(10):1051-1054. 3. BD MAX™ Cdiff [Package Insert]. Sparks, MD: Becton, Dickinson and Company; 2017. 4. Surawicz CM et al. Am J Gastroenterol. 2013;108(4):478-499. 5. Peterson LR, Robicsek A. Ann Intern Med. 2009;151(3):176-179.